CN111246807A

CN111246807A - Low temperature linear surgical stapler and method of use

Info

Publication number: CN111246807A
Application number: CN201880068297.1A
Authority: CN
Inventors: N.I.纳提夫; L.B.克里克斯诺夫; R.J.坦豪瑟; S.陈
Original assignee: Ethicon Inc
Current assignee: Ethicon Inc
Priority date: 2017-10-20
Filing date: 2018-10-15
Publication date: 2020-06-05
Also published as: JP2021500124A; WO2019079171A1; EP3697320A1; US20190117287A1; US10993759B2; AU2018352135A1

Abstract

The present invention relates to surgical instruments and methods for enhancing the properties of tissue repaired or engaged by surgical staples, and more particularly to surgical instruments and methods designed to enhance the properties of repaired or engaged tissue at a target surgical site. The present invention also relates to a cryogenic linear stapling instrument configured to pre-cool tissue engaged by a staple.

Description

Low temperature linear surgical stapler and method of use

Technical Field

The present invention relates to surgical instruments and methods for enhancing the properties of tissue repaired or engaged by surgical staples, and more particularly to surgical instruments and methods designed to pre-cool tissue engaged by staples to improve the results for repairing or engaging tissue at a target surgical site.

Background

The medical field has utilized various techniques to join or bond bodily tissues together. Historically, suturing has been an acceptable technique for re-engaging severed tissue and closing wounds. Suturing is accomplished with surgical needles and sutures, where the intended function of the suture is to hold the edges of the wound or tissue against each other during the healing process. Staples have in some cases been used to replace sutures when joining or anastomosing various bodily structures, such as, for example, the bowel. Surgical stapling devices for applying staples are typically designed to simultaneously cut and seal an elongated section of patient tissue.

Surgeons employ linear or circular/circular surgical stapling devices to sequentially or simultaneously apply one or more rows of surgical fasteners (e.g., staples) to body tissue to join sections of body tissue together and/or to create an anastomosis. Linear surgical stapling devices typically include a pair of jaws or fingers between which body tissue to be engaged is placed. When the surgical stapling device is actuated, the firing bar moves longitudinally and contacts the staple driving member in one of the jaws, and the surgical staples are pushed through the body tissue and advanced to and against the anvil in the opposing jaw, thereby crimping the staples closed. A blade may be provided to cut between rows/lines of staples.

Many surgical staplers are known for use in open procedures and endoscopic procedures. Some such staplers are operable to clamp layers of tissue, cut through the clamped layers of tissue, and drive staples through the layers of tissue to substantially seal the severed layers of tissue together near the severed ends of the layers of tissue. Only exemplary surgical staplers are disclosed in the following U.S. patents: U.S. Pat. No. 4,805,823 entitled "Pocket Configuration for Internal OrganStaplers" published on 21.2.1989; U.S. patent 5,415,334 entitled "scientific mapler and maple Cartidge" published 16.5.1995; U.S. Pat. No. 5,465,895 entitled "surgical Stapler Instrument" published 11/14/1995; U.S. patent 5,597,107 entitled "surgical stapler Instrument" published on 28.1.1997; U.S. patent 5,632,432 entitled "surgical instrument" published 27/5/1997; U.S. Pat. No. 5,673,840, entitled "Surgical Instrument", published 10/7/1997; U.S. Pat. No. 5,704,534 entitled "engineering Assembly for surgical Instruments" published on 6.1.1998; U.S. patent 5,814,055 entitled "surgical clamping Mechanism" published on 29.9.1998; U.S. Pat. No. 6,978,921 entitled "surgical Staplng Instrument incorporation an E-Beam fastening Mechanism" published at 27.12.2005; U.S. Pat. No. 8,7,000,818 entitled "Surgical stabilizing Instrument cutting and fastening Systems" published 2006, 2/21/2006; U.S. Pat. No. 5/12/2006 entitled "Surgical stabilizing Instrument stabilizing A Firing Lockout for an UnclosedAnvil" U.S. Pat. No. 7,143,923; U.S. Pat. No. 4,7,303,108 entitled "Surgical Stapling Instrument Incorporating a Multi-Stroke Firing Mechanism with a FlexibleRack" published on 12/4/2007; U.S. Pat. No. 5,7,367,485 entitled "scientific Stapling Instrument incorporation a Multistroke Firing Mechanism a RotaryTransmission" published 5/6.2008; U.S. Pat. No. 8,7,380,695 entitled "Surgical Stapling Instrument bathing a Single Lock out Mechanism for prediction of training" published 3.6.2008; U.S. Pat. No. 7,380,696 entitled "engineering scientific sampling Instrument Incorporating a Two-Piece E-Beam fastening Mechanism" published on 3.6.2008; U.S. patent 7,404,508 entitled "scientific labeling and Cutting Device" published 29.7.2008; U.S. Pat. No. 5,7,434,715 entitled "Surgical stabilizing Instrument viewing with Opening Lockout" published 10/14.2008; U.S. patent 7,721,930 entitled "DisposableCrigdge with Adhesive for Use with a splicing Device" published on 25.5.2010; U.S. Pat. No. 4,410, 8,408,439 entitled "Surgical stabilizing Instrument with an annular End Effect" published on 2.4.2013; and U.S. Pat. No. 8,453,914 entitled "Motor-Driven scientific Current Instrument with Electric Actuator directive control Assembly" published on 6/4/2013. The disclosure of each of the above-referenced U.S. patents is incorporated herein by reference.

Although many of the surgical staplers referred to above are used in endoscopic procedures, such surgical staplers may also be used in open procedures and/or other non-endoscopic procedures. By way of example only, a surgical stapler can be inserted through a thoracotomy and thereby positioned between a patient's ribs to access one or more organs in a thoracic surgical procedure that does not use a trocar as a conduit for the stapler. Such procedures may include the use of a stapler to cut and close blood vessels leading to the lungs. For example, prior to removal of the organ from the chest cavity, blood vessels leading to the organ may be severed and closed by a stapler. The surgical stapler can be used in a variety of other settings and procedures. An example of a Surgical stapler that may be particularly suited for use with thoracotomy is disclosed in U.S. patent 9,186,142 entitled "Surgical Instrument End Effector apparatus with Pinion and operating Racks," the disclosure of which is incorporated herein by reference.

Annular or circular surgical stapling devices typically include an annular cartridge assembly (which includes a plurality of annular rows of staples, typically two or three), an anvil assembly operably associated with the annular cartridge assembly, and an annular knife blade disposed within the rows of staples. In general, an end-to-end anastomosis stapler typically places a series or set of staples into a proximal section of a patient's intestine or other tubular organ. The resulting anastomosis includes a reverse section of the intestine including a plurality of "B" shaped staples to maintain a secure connection between proximal sections of the intestine.

U.S. patent 5,173,133 "METHOD FOR ANNEALING STAPLER ANVILS" discloses a METHOD FOR annealing a defined portion of an anvil member FOR use in a surgical stapler, the METHOD comprising: a) providing a means for heating; b) placing the anvil member in a hanger apparatus comprising a member made of a thermally conductive material and a treatment apparatus configured and dimensioned to receive the anvil such that a first portion of an outer surface of the anvil is in thermally conductive contact with an inner surface of the receiving apparatus and a second portion of the outer surface of the anvil is exposed; c) positioning the hanger adjacent the heating device such that the defined portion of the second portion of the outer surface of the anvil member is within a heating range of the heating device; and d) operating the heating device such that the defined exposed portion of the anvil member is heated to an annealing temperature.

U.S. patent 9,005,199 "Heat management configurations for controlling thermal delivery from electrical instruments" discloses a surgical instrument comprising: an end effector, the end effector comprising: a first jaw comprising an electrode having a distal end; a second jaw, wherein the first jaw and the second jaw are operably coupled together; and a cutting member configured to translate relative to the first jaw between a retracted position and a fully advanced position, wherein the cutting member comprises a cutting surface and a body, wherein the body defines a cavity and at least one opening in communication with the cavity, and wherein the at least one cutting member opening is adjacent the distal end of the electrode when the cutting member is in the fully advanced position.

U.S. patent 8,679,114, "incorporated Rapid ablation in tissue fusion processing", discloses an electrode sealing assembly designed for use with an electrosurgical instrument for sealing tissue, comprising: first and second jaw members movable in spaced relation relative to one another from a first position to at least one second position for grasping tissue therebetween, the jaw members comprising: an electrically conductive seal plate disposed in opposing relation to one another, the at least one jaw member comprising: a thermoelectric cooling plate having a first surface in direct contact with an outer surface of the sealing plate, the thermoelectric cooling plate including first and second electrical connections disposed on opposite sides of the thermoelectric cooling plate, the first electrical connection configured to selectively transmit a first electrical potential and the second electrical connection configured to selectively transmit a second electrical potential such that heat generated by the sealing plate is transferred away from the tissue via the thermoelectric cooling plate, wherein the electrically conductive sealing plates each include an inward lateral side, the inward lateral side and the first surface of the thermoelectric cooling plate configured to form a knife slot therebetween, the knife slot sized to receive a blade therein, the blade disposed substantially adjacent and proximate to the thermoelectric cooling plate to enable heat transfer from the blade to the thermoelectric cooling plate, and wherein the at least one jaw member further comprises a first heat sink disposed in contact with the second surface of the thermoelectric cooling plate, the first heat sink being made of a thermally and electrically conductive cooling polymer.

U.S. patent 7,815,641 "Surgical instrument and method for use therof" discloses a Surgical instrument for treating tissue comprising: a handpiece; and a tissue engaging portion arranged to be received by the handpiece, the tissue engaging portion including opposing first and second jaw members having open and closed positions for engaging the tissue therebetween, the first and second jaw members being arranged to receive surgical energy from a surgical generator, and at least one cooling member spaced apart from at least one of the first and second jaw members, the at least one cooling member being independently movable relative to the jaw members and having open and closed positions for engaging the tissue, wherein positioning the jaw members in their closed positions and applying surgical energy to the tissue allows the tissue to be treated, and positioning the at least one cooling member in its closed position provides at least one of a pressure gradient or a thermal gradient between the jaw member and the at least one cooling member.

U.S. patent application publication 2014/0180281 "ELECTRIC STAPLER DEVICE" discloses a clamped end effector assembly comprising: a first jaw member and a second jaw member, at least one of the jaw members being movable relative to each other between a spaced-apart position and an approximated position for grasping tissue therebetween, each jaw member comprising: a plurality of spaced apart seal plates, wherein each seal plate corresponds to a seal plate on an opposing jaw member to form a pair of seal plates, each pair of seal plates being individually activatable; and a cutting element, wherein when the first and second jaw members are in the approximated position, the pair of seal plates closer to the cutting element define a gap therebetween that is less than a gap between the pair of seal plates distal from the cutting element.

Us patent 4,281,785 "stabilizing apparatus and method and thermoplastic resins used thermally with" discloses a suturing device for an assembly of suturing members, said device having a suturing head for carrying and continuously dispensing a plurality of staples entirely made of thermoplastic material, each of said staples comprising a loop of string and a pair of legs extending in substantially parallel relationship from opposite ends of said loop of string; a staple driving arrangement in the head for driving each of the staples through the assembly once each staple is dispensed into a driving position; and a compression anvil for compressing an outer portion of the leg of each staple, the improvement wherein the anvil has a heating portion comprising an integral heater for thermoforming the outer portion of the leg in compressed relation after the leg is handled by the assembly; and a cooling portion comprising integral cooling means for cooling the outer portions of the legs after they have been formed, and the apparatus comprises a single support for the anvil and its heating and cooling portions mounted for pivotal movement about a single pivot to enable the heating portion to be moved into position to provide the thermoforming of the outer portions and then the cooling portion to be moved into position to provide the cooling of the outer portions.

U.S. patent 7,169,146, "Electrosurgical probe and method of use," discloses an Electrosurgical instrument for delivering energy to tissue, comprising: a working end for engaging the tissue; a surface layer at an outer portion of the working end, the surface layer comprising a matrix of a polymeric PTC composition adapted to deliver electrical current to the tissue; and a cooling structure at an interior portion of the working end; wherein the cooling structure cools the PTC matrix to reduce the temperature of one or more portions of the PTC matrix.

In us patent 3,794,039 "aparatus FOR CRYOSURGERY" which discloses an APPARATUS FOR CRYOSURGERY having a central unit including a supply of liquid cryogenic coolant, control and regulation means, and a sub-atmospheric suction device connected to a probe FOR freezing tissue, the improvement comprising: a. a cryogenic probe comprising a gripping member having a hollow cryogen coolant feed line supported by the gripping member, the line being open at its distal end and connected at one end to the cryogen coolant supply for delivering liquid coolant for direct impingement on tissue to be frozen; b. a hollow cryogenic coolant return line open at a transparent end thereof disposed concentrically around the feed line to form a space therebetween; means for conveying said space to said sub-atmospheric suction means for returning vaporized coolant from said feed line, the open end of said feed line being recessed relative to the corresponding open end of said return line.

U.S. patent 6,656,177 "electronic systems and techniques for sealing tissue" discloses a jaw assembly for a surgical instrument comprising: an instrument working end carrying first and second jaws actuatable between first and second open positions, the jaws in the closed position defining a longitudinal axis, and wherein the jaws further define outer and inner jaw faces having a longitudinal length; an axially extending member actuatable from a first retracted position to a second extended position in an axial passage extending the length of the outer jaw face and the inner jaw face; and wherein the axially extending member defines a first cam surface portion that engages a mating second cam surface portion that extends the entire length of the inner jaw face to actuate the jaws toward the closed position and prevent flexing apart of the jaws.

U.S. patent 6,694,984 "Liver surgery" discloses a method of reducing blood loss during Liver surgery in which diseased or damaged tissue is removed from the Liver by delivery of thermal energy to the tissue by a probe, wherein the method is performed to define a Liver resection with a coagulative necrotic area at least 2cm wide in the surgery, the improvement comprising: multiple probe applications, followed by dissection with a thin-walled tissue scalpel, and suturing of blood vessels larger than about 2.5 mm.

U.S. patent application publication 2014/0371735, "Electrorosurgicalinginent END effector with PREHEATING ELEMENT," discloses an apparatus for operating on tissue, wherein the apparatus includes an END effector comprising: (a) a first jaw; (b) a second jaw, wherein the first jaw is selectively pivotable toward and away from the second jaw to capture tissue; (c) at least one pre-heating element, wherein the at least one pre-heating element is disposed within one or both of the first jaw or the second jaw, wherein the at least one pre-heating element is operable to heat to transfer heat to tissue captured between the first jaw and the second jaw; and (d) at least one electrode, wherein the at least one electrode is operable to apply RF energy to tissue captured between the first jaw and the second jaw.

U.S. patent application publication 2016/0120601, "electrosurgicalingintry WITH SENSOR," discloses a device for operating on tissue, the device comprising: (a) a main body; (b) a shaft extending distally from the body; (c) an end effector configured to receive energy from an energy source, wherein the end effector comprises: (i) a first jaw and (ii) a second jaw, wherein the second jaw is pivotable relative to the first jaw to transition the end effector from an open configuration to a closed configuration, wherein the first jaw and the second jaw define a closure gap between one another when the end effector is in the closed configuration; and (d) a sensor, wherein the sensor is operable to detect when the end effector is in the closed configuration, wherein the sensor is in communication with the energy source, wherein the sensor is operable to transmit a signal to the energy source when the sensor detects that the end effector is in the closed configuration.

U.S. patent 7,762,445, "electric stapling apparatus," discloses a surgical stapler comprising: an anvil member having a plurality of staple forming pockets defined therein for deforming a corresponding plurality of surgical staples, the anvil including an electrically insulative material disposed on a tissue contacting surface thereof, wherein at least one of the plurality of staple forming pockets is coated with the electrically insulative material, wherein the electrically insulative material is selectively removable, and wherein the electrically insulative material is selectively removable from the tissue contacting surface of the anvil member during firing of the surgical stapler; a cartridge assembly comprising a staple cartridge defining a tissue contacting surface and configured to hold a plurality of electrically conductive surgical staples; an electrical conduit adapted to be connected to a surgical generator; and an actuator operably connected to the cartridge assembly for deploying the plurality of surgical staples from the staple cartridge against the anvil member, the actuator being movable within the cartridge assembly and coupled to the electrical conduit, the actuator comprising an electrically conductive actuation sled and an electrically conductive blade, wherein the electrical conduit is configured for transferring thermal energy through the actuation sled to the blade and the staples.

U.S. patent 5,807,393 "Surgical tissue manipulating device with locking mechanism" discloses a Surgical instrument comprising: a tissue treatment section comprising: a therapeutic energy delivery device arranged to deliver therapeutic energy to tissue, and a tissue manipulation device; a shaft coupled to the tissue treatment portion, the shaft including a therapeutic energy delivery device operably coupled to the therapeutic energy delivery device, the energy delivery device and the energy delivery device adapted to be actuated to deliver therapeutic energy to tissue; a tissue manipulation actuation device having a locked position and an unlocked position, the tissue manipulation actuation device extending through the shaft and being operably coupled to the tissue manipulation device; a locking mechanism coupled to the tissue manipulation actuation device for moving the tissue manipulation actuation device from the locked position to the unlocked position after the therapeutic energy delivery device and the therapeutic energy delivery device are actuated to deliver therapeutic energy to tissue; a tissue parameter measurement and instrument control device adapted to provide a feedback signal representative of a tissue treatment status of tissue treated by the therapeutic energy delivery device, the parameter measurement and instrument control device coupled to the tissue treatment portion of the instrument; and a status indicator coupled to the parameter measurement and instrument control device, the status indicator being arranged to provide a user perceptible signal indicative of a tissue treatment status.

U.S. Pat. No. 8,715,277 "Control of jaw compression in surgical linkage end effector with open jaw members" discloses a surgical instrument comprising: an end effector comprising a distal end and a proximal end, wherein the end effector comprises: a first jaw member comprising a distal end and a proximal end, wherein the proximal end of the first jaw member comprises a pin; a second jaw member opposite the first jaw member, wherein second jaw comprises a distal end and a proximal end, wherein the proximal end of the second jaw member comprises a multi-lobe cam slot having at least three lobes, wherein the pin of the first jaw member is disposed within and movable within the multi-lobe cam slot between the three lobes, wherein the first jaw member is movable relative to the second jaw member such that the first and second jaw members are transitionable between an open position and a closed position such that the first and second jaw members are in the open position when the pin of the first jaw member is in a first lobe of the multi-lobe cam slot and the pin of the first jaw member is in a second lobe of the multi-lobe cam slot, the first and second jaw members are in the closed position, and wherein the pin of the first jaw member moves into a third lobe of the multi-lobe cam slot when the pin transitions from the first lobe to the second lobe; and a latch at a distal end of the end effector for latching the distal end of the first jaw member to the distal end of the second jaw member when the first and second jaw members are in the closed position.

U.S. patent 9,259,265 "Surgical instruments for fastening tissue" discloses an end effector configured to be attached to a Surgical instrument including a closure beam, the end effector including: a first jaw comprising an electrode; a second jaw, wherein at least one of the first jaw and the second jaw is movable relative to the other jaw between an open position and a closed position, and wherein in the closed position a first region of tissue is configured to be positioned intermediate the first jaw and the second jaw and configured to be compressed; the first jaw comprises: a first slider member movably attached to the first jaw and movable relative to the electrode and the closure beam, wherein the first slider member comprises a first tissue contacting surface configured to engage a second region of tissue; and the second jaw comprises: a second slider member movably attached to the second jaw and movable relative to the electrode and the closure beam, wherein the second slider member comprises a second tissue contacting surface configured to engage a second region of the tissue; a longitudinal slot; and a cutting member slidable within the longitudinal slot; wherein the first and second slides are configured to change a width of the end effector and apply a tensile force to tissue intermediate the first and second regions of tissue as the first and second slides move laterally relative to the electrode and the longitudinal slot.

U.S. patent 8,911,486 "Implantable devices for thermal therapy and related methods" discloses a method of applying thermal therapy to tissue comprising: forming a tissue opening in a patient to access a target site within the patient; passing a thermic device through the tissue opening; placing the thermic device at the target site; closing the tissue opening with the thermic device at the target site; applying or continuing to apply heat therapy to the target site by the thermic device after closing the tissue opening; and after closing the tissue opening, pulling a tether attached to the thermic device to remove the thermic device from the patient without reopening the tissue opening; wherein the thermic device comprises a malleable pad.

U.S. patent 9,295,514 "Surgical devices with close quartz insulating devices" discloses an apparatus comprising: a shaft section extending longitudinally along a first plane; an end effector comprising a first jaw and a second jaw configured to pivotally open and close about a pivot point relative to the first plane in a second plane, wherein the first plane is orthogonal to the second plane; an articulation section disposed between the shaft section and the end effector, the articulation section configured to articulate in the second plane relative to the first plane in response to a rotatable articulation control mechanism, the articulation section comprising a molded member defining at least one slot and at least one groove; the at least one slot comprises a first slot extending longitudinally along a length of the molding member, the first slot comprising an opening at one side of the molding member and terminating on another side within the molding member; a longitudinally slidable blade comprising an upper flange and a lower flange; a flexible firing element comprising an upper flexible band and a lower flexible band slidably positioned within the at least one slot, the upper flexible band connected to the upper flange of the blade and the lower flexible band connected to the lower flange of the blade; wherein at least one of the first jaw and the second jaw comprises an electrode.

Us patent 5,211,646 "Cryogenic scalpel" discloses a cryosurgical knife for performing a surgical operation on biological tissue of parenchyma tissue, comprising: a hollow housing having an interior space; a working portion connected to the hollow housing and having a body extending in a longitudinal direction; a heat exchanger device for establishing a zone for cooling biological tissue during a surgical procedure by supplying a cooling fluid to the interior space; a blade having two ends and a cutting lip, the ends of the blade being secured to the heat exchanger device; a coolant freely circulating through the heat exchanger device; a conduit housed in the interior space of the hollow shell and in communication with the heat exchanger component; an electromechanical oscillation source housed in said hollow casing to establish a reciprocating movement of said working portion with an electromechanical oscillation frequency, with the result that heating of said blade is excluded and biological tissue of parenchyma is separated by simultaneous cooling in said cooling zone produced by said heat exchanger device; and means for imparting electromechanical oscillations to the working portion so as to impart reciprocating motion to the blade; the means for imparting is connected between the electromagnetic oscillation source and the blade.

There is a need to improve the viability of the tissue being stapled and the viability of the resulting joint to improve healing and prevent tissue necrosis and leakage.

Disclosure of Invention

The present invention relates to surgical instruments and methods for enhancing the properties of tissue repaired or engaged by surgical staples, and more particularly to surgical instruments and methods designed to enhance the properties of repaired or engaged tissue at a target surgical site, particularly when suturing tissue segments to improve tissue viability in hypoxic conditions, prevent tissue inflammation, and prevent leakage. The present invention also relates to a cryogenic linear stapling instrument configured to pre-cool tissue engaged by a staple.

In one aspect, the present invention relates to a cryogenic linear surgical stapler for stapling and optionally excising at least one tissue, comprising: a body, a shaft assembly, and an end effector, wherein the end effector comprises a lower jaw configured to receive a staple cartridge, an anvil pivotable toward and away from the lower jaw, and a translatable knife member; a disposable cartridge mounted in the lower jaw, the cartridge containing a plurality of deployable staples in an array separated by a tissue resection channel through which the knife member is translatable; the anvil has a plurality of staple forming pockets on a tissue-facing surface aligned with the deployable staples; wherein the anvil comprises at least one cooling zone on or within the anvil.

The cooling zone may be a reservoir or compartment filled with a coolant, wherein the coolant may be a fluid having a high heat capacity. The coolant may be at least partially frozen or may be a combination of frozen and melted coolant. Depending on the composition, the coolant may be water, alcohol, glycerol, glycol, or mixtures thereof, in whole or in part. In one compositional embodiment, the coolant may be a glycerol-water mixture having a melting point above 0 ℃ but below 8 ℃. In another embodiment, the coolant may be an instant coolant. In one compositional embodiment, the coolant may be ethanol, methanol, or an ethanol-water mixture.

In one alternative, the reservoir is connected to the recirculation pump and the cooler via a supply channel and a discharge channel. In other embodiments, the cooling region may comprise a Peltier element or a cooling region that is a compressed gas cooling orifice connected to a gas conduit and a compressed gas source. In another embodiment, the cooling zone can comprise a heat pipe configured to transfer thermal energy between the anvil and the cooling zone in the stapler handle. A thermally conductive region may extend from a tissue facing surface that is in contact with the reservoir toward the anvil. Optionally, the reservoir may have at least one window to enable visualization of the one or more coolants contained therein.

The present invention also relates to a method of suturing tissue, the method comprising the steps of:

a) inserting the staple cartridge into the lower jaw;

b) capturing the tissue between the anvil and the staple cartridge;

c) cooling the tissue by conductive heat transfer between the tissue and the cooling zone while the tissue is captured between the anvil and the staple cartridge;

d) translating the knife member distally from a proximal position to a distal position, cutting the captured tissue substantially simultaneously, thereby forming a resected tissue edge, and driving the plurality of staples of the staple cartridge through the captured tissue,

e) optionally continuing to cool the stapled tissue;

f) removing the surgical stapler from contact with tissue.

In various embodiments, the cooling zone is pre-cooled or frozen prior to step a) or b) or c).

Drawings

FIG. 1 illustrates a perspective view of an exemplary articulating surgical stapling instrument;

FIG. 2 shows a side elevational view of the instrument of FIG. 1;

FIG. 3 illustrates a perspective view of the end effector of the instrument of FIG. 1 with the end effector in a closed configuration;

FIG. 4 shows a perspective view of the end effector of FIG. 3 with the end effector in an open configuration;

FIG. 5 shows an exploded perspective view of the end effector of FIG. 3;

FIG. 6 illustrates a cross-sectional end view of the end effector of FIG. 3 taken along line 6-6 of FIG. 4;

FIG. 7 illustrates a perspective view of an exemplary cartridge that can be incorporated into the end effector of FIG. 3;

FIG. 8 illustrates an exploded perspective view of an alternative exemplary surgical stapling instrument;

FIG. 9 shows a schematic cross-sectional view of an assembled stapler of the present invention having a cooling zone in the anvil;

FIG. 10 shows a schematic cross-sectional view of an alternative assembled stapler of the present invention having a cooling zone in the anvil;

FIG. 11 shows a schematic cross-sectional view of an exemplary anvil;

12A-12G show schematic cross-sectional views of an anvil of the present invention;

fig. 13A-13B show schematic cross-sectional views of an anvil of the present invention;

FIG. 14A shows a schematic cross-sectional view of an assembled stapler of the present invention having an attachable and detachable external coolant compartment on the anvil;

FIG. 14B shows a schematic cross-sectional view of an anvil of the present invention;

FIG. 14C shows a schematic perspective view of an attachable and detachable external coolant compartment;

FIG. 15 shows a schematic cross-sectional view of an assembled stapler of the present invention;

FIG. 16 shows a schematic cross-sectional view of an assembled stapler of the invention;

FIGS. 17-18 show schematic cross-sectional views of components of the stapler of the invention in operation.

Detailed Description

Surgical procedures often involve joining two or more layers of tissue together and optionally simultaneously sectioning a portion of the tissue along a staple line. A typical surgical stapling instrument, such as a surgical linear stapling instrument, has a staple-containing component and an opposing anvil component between which at least two tissue layers to be joined are compressed prior to delivery of staples from the staple-containing component, whereby the staples penetrate the two tissue layers and bend, deform, or close against the opposing anvil component. For linear surgical staplers, the disposable stapling cartridge is a component comprising staples, the cartridge is typically mounted in a jaw of the device, such as in a lower jaw adapted to hold the cartridge, and the opposite or upper jaw is an anvil component. The cartridge has slots disposed between adjacent, parallel rows of staples and extending substantially the entire length of the rows of staples. The stapler includes a firing device for the staples and a cutting device movable along the slot.

Referring now to FIGS. 1-6, there is shown a SURGICAL stapling instrument or stapler, wherein the drawings are taken from U.S. patent publication 2015/0374373A1, "METHOD OF USING LOCKOUT FEATURES FOR SURGICAL STAPLERCARTRIDGE," which is incorporated herein by reference in its entirety.

Fig. 1 illustrates an exemplary surgical stapling and severing instrument (10) that includes a handle assembly (20), a shaft assembly (30), and an end effector (40). The distal portions of the end effector (40) and shaft assembly (30) are sized for insertion through the trocar cannula into a surgical site of a patient in the unarticulated state shown in fig. 1 for performing a surgical procedure. By way of example only, such a trocar may be inserted into a patient's abdomen from between the patient's two ribs or elsewhere. In some cases, the instrument (10) is used without the presence of a trocar. For example, the end effector (40) and distal portion of the shaft assembly (30) may be inserted directly through a thoracotomy or other type of incision. Terms such as "proximal" and "distal" are used herein with respect to a clinician gripping a handle assembly (20) of an instrument (10). Thus, the end effector (40) is distal with respect to the more proximal handle assembly (20). It will also be appreciated that, for convenience and clarity, spatial terms such as "vertical" and "horizontal" are used herein in connection with the illustrations. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.

As shown in fig. 1-2, the handle assembly (20) of the present example includes a pistol grip (22), a closure trigger (24), and a firing trigger (26). Each trigger (24,26) is selectively pivotable toward and away from the pistol grip (22). The handle assembly (20) further includes an anvil release button (25), a firing beam reverse switch (27), and a removable battery pack (28). The handle assembly (20) may have a variety of other components, features, and operability in addition to or in place of any of those described above.

As shown in fig. 1-3, the shaft assembly (30) of the present example includes an outer closure tube (32), an articulation section (34), and a closure ring (36) that is further coupled to an end effector (40). A closure tube (32) extends along the length of the shaft assembly (30). A closure ring (36) is positioned distal to the articulation section (34). The closure tube (32) and closure ring (36) are configured to longitudinally translate relative to the handle assembly (20). Longitudinal translation of the closure tube (32) is transmitted to the closure ring (36) via the articulation section 34.

The articulation section (34) is operable to laterally deflect the closure ring (36) and the end effector (40) laterally away from the Longitudinal Axis (LA) of the shaft assembly (30) at a desired angle (a). Thus, the end effector (40) may reach behind an organ or proximate tissue from a desired angle or for other reasons. In some versions, the articulation section (34) is configured to deflect the end effector (40) along a single plane. In some other versions, the articulation section (34) is configured to deflect the end effector along more than one plane. In this example, articulation is controlled by an articulation control knob (35) located at the proximal end of the shaft assembly (30). The knob (35) is rotatable about an axis perpendicular to a Longitudinal Axis (LA) of the shaft assembly (30). In response to rotation of the knob (35), the closure ring (36) and end effector (40) pivot about an axis perpendicular to the Longitudinal Axis (LA) of the shaft assembly (30). By way of example only, clockwise rotation of the knob (35) may cause corresponding clockwise pivoting of the closure ring (36) and end effector (40) at the articulation section (34). The articulation section (34) is configured to transmit a longitudinal translation of the closure tube (32) to the closure ring (36) regardless of whether the articulation section (34) is in a straight configuration or an articulated configuration.

As shown in fig. 1-2, the shaft assembly (30) of the present example further includes a knob (31). The knob (31) is operable to rotate the entire shaft assembly (30) and end effector (40) relative to the handle assembly (20) about the Longitudinal Axis (LA) of the shaft assembly (30). In some versions, the knob (31) is operable to selectively lock the angular positioning of the shaft assembly (30) and end effector (40) relative to the handle assembly (20) about the Longitudinal Axis (LA) of the shaft assembly (30). For example, the knob (31) is translatable between a first longitudinal position in which the shaft assembly (30) and the end effector (40) are rotatable relative to the handle assembly (20) about the Longitudinal Axis (LA) of the shaft assembly (30); in the second longitudinal position, the shaft assembly (30) and the end effector (40) are not rotatable relative to the handle assembly (20) about the Longitudinal Axis (LA) of the shaft assembly (30). Of course, the shaft assembly (30) may have a variety of other components, features, and operability in addition to or in place of any of those described above.

As also shown in fig. 1-3, the end effector (40) of the present example includes a lower jaw (50) and a pivotable anvil (60). The anvil (60) includes a pair of integral outwardly extending pins (66) disposed in corresponding curved slots (54) of the lower jaw (50). The pin (66) and slot (54) are shown in fig. 5. The anvil (60) is pivotable toward and away from the lower jaw (50) between an open position (shown in fig. 2 and 4) and a closed position (shown in fig. 1, 3). As seen in fig. 5, the lower jaw (50) of the present example defines a channel (52) configured to receive a staple cartridge (70). A staple cartridge (70) may be inserted into the channel (52), the end effector (40) may be actuated, and then the staple cartridge (70) may be removed and replaced with another staple cartridge (70). The lower jaw (50) thus releasably holds the staple cartridge (70) in alignment with the anvil (60) to actuate the end effector (40).

As seen in fig. 4-7, the staple cartridge (70) of the present example includes a cartridge body (71) and a tray (76) secured to the underside of the cartridge body (71). The upper side of the cartridge body (71) presents a platform (73) against which the tissue can be pressed when the anvil (60) is in the closed position. The cartridge body (71) further defines a longitudinally extending channel (72) and a plurality of staple pockets (74). A staple (77) is positioned in each staple pocket (74). A staple driver (75) is also positioned in each staple pocket (74) below the corresponding staple (77) and above the tray (76). The staple drivers (75) are operable to translate upwardly in the staple pockets (74) to drive the staples (77) upwardly through the staple pockets (74) and into engagement with the anvil (60). The staple drivers (75) are driven upwardly by a wedge sled (78) that is captured between the cartridge body (71) and the tray (76) and translates longitudinally through the cartridge body (71). The wedge sled (78) includes a pair of obliquely angled cam surfaces (79) configured to engage the staple drivers (75) to drive the staple drivers (75) upward as the wedge sled (78) translates longitudinally through the cartridge (70).

The configuration of the staple cartridge (70) can be varied in a number of ways. For example, the staple cartridge (70) of the present example includes two longitudinally extending rows of staple pockets (74) located on one side of the channel (72); and another set of two longitudinally extending rows of staple pockets (74) located on the other side of the channel (72). However, in some other versions, staple cartridge (70) includes three, one, or some other number of staple pockets (74) on each side of channel (72).

As seen in fig. 4, the anvil (60) of the present example includes a longitudinally extending channel (62) and a plurality of staple forming pockets (64). The channel (62) is configured to align with a channel (72) of a staple cartridge (70) when the anvil (60) is in the closed position. Each staple forming pocket (64) is positioned to overlie a corresponding staple pocket (74) of the staple cartridge (70) when the anvil (60) is in the closed position. The staple forming pockets (64) are configured to deform the legs of the staples (77) as the staples (77) are driven through tissue and into the anvil (60). The staple forming pockets (64) are configured to bend the legs of the staples (77) to secure the formed staples (77) in tissue.

In the present example, the knife member (80) is configured to translate through the end effector (40). As seen in fig. 5, a knife member (80) is secured to a distal end of the firing beam 82. As seen in fig. 4 and 6, the knife member (80) is positioned in the channel (62) of the anvil (60) and the channel (72) of the staple cartridge (70). The knife member (80) includes a distally presented cutting edge (84) configured to cut tissue compressed between the anvil (60) and the deck (73) of the staple cartridge (70) as the knife member (80) is translated distally through the end effector (40).

In some versions, the end effector (40) includes a lockout feature configured to prevent distal advancement of the knife member (80) through the end effector (40) when the staple cartridge (70) is not inserted in the lower jaw (50). Additionally or alternatively, the end effector (40) may include a lockout feature configured to prevent the knife member (80) from being advanced distally through the end effector (40) when a staple cartridge (70) that has been actuated once (e.g., with all staples (77) disposed therein) is inserted in the lower jaw (50). Alternatively, the end effector (40) may simply omit such lockout features.

In the present example, the anvil (60) is driven toward the lower jaw (50) by advancing the closure ring (36) distally relative to the end effector (40). In response to distal translation of the closure ring (36) relative to the end effector (40), the closure ring (36) cooperates with the anvil (60) via a camming action to drive the anvil (60) toward the lower jaw (50). Similarly, in response to proximal translation of the closure ring (36) relative to the end effector (40), the closure ring (36) may cooperate with the anvil (60) to open the anvil (60) away from the lower jaw (50).

As noted above, the handle assembly (20) includes a pistol grip (22) and a closure trigger (24). As also noted above, in response to distal advancement of the closure ring (36), the anvil (60) closes toward the lower jaw (50). In this example, the closure trigger (24) may pivot toward the pistol grip (22) to drive the closure tube (32) and closure ring (36) distally. Various suitable components that may be used to translate the pivotal movement of the closure trigger (24) toward the pistol grip (22) into distal translation of the closure tube (32) and closure ring (36) relative to the handle assembly (20) will be apparent to those of ordinary skill in the art in view of the teachings herein. When the closure trigger (24) reaches a fully pivoted state such that the anvil (60) is in a fully closed position relative to the lower jaw (50), a locking feature in the handle assembly (20) locks the position of the trigger (24) and closure tube (32), thereby locking the anvil (60) in the fully closed position relative to the lower jaw (50). These locking features are released by actuating an anvil release button (25). The anvil release button (25) is configured and positioned to be actuatable by a thumb of a hand of an operator grasping the pistol grip (22). In other words, the operator may grasp the pistol grip (22) with one hand, actuate the closure trigger (24) with one or more fingers of the same hand, and then actuate the anvil release button (25) with the thumb of the same hand, without releasing the grasp of the pistol grip (22) with the same hand. Other suitable features may be used to actuate the anvil (60).

Referring now to fig. 8, an alternative exemplary Surgical stapling instrument or linear stapler device is shown which is adapted by U.S. patent 5,275,323, "Surgical stapler", and is incorporated herein by reference in its entirety. As seen in fig. 8, the surgical stapler 11 includes an upper member 300, a firing device 400, a lower member 500, and a staple cartridge 600.

The cartridge 600 is fitted in the lower member 500. Specifically, a forward portion of staple cartridge 600 fits into lower jaw channel 540. More specifically, parallel side walls 610 of staple cartridge 600 fit within lower jaw channel 540. The rear portion of staple cartridge 600 has a breakable cross-member 660. Such a breakable cross member 660 is placed on top of the cartridge lockout device 470 of the firing device 400. At the same time, two legs 650 in the rearwardly extending surface 620 secure the staple cartridge 600 to the lower member 500.

In fig. 8, the upper part 300 has a rear upper handle portion 310 and a front upper jaw portion or anvil 320. Likewise, lower member 500 includes a rear movable lower handle portion 510 and a front lower jaw portion 530. The embodiment of the surgical stapler shown in FIG. 8 incorporates a firing device 400, a leaf spring 570, and a staple cartridge 600 into a lower member 500. However, these elements may be placed in the upper member 300 instead of the lower member 500.

The lower handle portion 510 shown in fig. 8 is movable, more particularly pivotable, between two locking positions. In the first locked position, the movable lower handle portion 510 is positioned at an oblique angle to the lower jaw portion 530. During the first locked position, C-shaped member 520 of lower handle 510 is disengaged from fixed locking pin 330. Upper member 300 and lower member 500 may be separated before or after operation of stapler 11 at the first locked position, respectively. In the second locked position, on the other hand, the C-shaped member 520 of the movable lower handle 510 locks the upper and

lower components

300 and 500 together. In the second, locked position, the movable lower handle portion 510 is parallel to the lower jaw portion 520. This second locked position occurs by engaging the static locking pin 330 with the C-shaped member 520. This movable handle section design may be located on upper handle section 310 or lower handle section 510, respectively.

The firing knob 590 activates the firing device 400. The firing device 400 also includes a top assembly 700 and includes a cutting device, such as a knife blade assembly 440. Cutting surface 450 is included in blade assembly 440. Although FIG. 8 shows a blade assembly, tissue may be cut in many ways other than by a blade or razor.

The firing knob 590 is manually pushed toward the staple cartridge 600 when the knife-blade assembly 440 is aligned with the slot 640. Pushing the firing knob 590 moves the knife blade assembly 440 forward toward the staple cartridge 600. The blade cutting surface 450 is then moved through the slot 640 of the staple cartridge 600 while the staples are advanced from the staple cartridge 600 through the longitudinal slots 630. In some staple cartridge 600 embodiments, a knife blade assembly is incorporated into the staple cartridge 600.

Other versions and modifications of surgical staplers 10, 11 are known to those skilled in the art, all of which include a

staple cartridge

70 or 600 having a plurality of staple pockets 74 or longitudinal slots 630 containing staples 77 (staples not shown in FIG. 8), wherein the staple pockets 74 or longitudinal slots 630 are generally arranged in one or more rows on either side of a longitudinally extending channel 72 or slot 640. There are typically at least two rows and in many cases at least three rows of staple pockets 74 or longitudinal slots 630 on each side of the longitudinally extending channel 72 or slot 640, with the staple pockets 74 or longitudinal slots 630 in each row typically staggered or offset relative to the pockets or slots in adjacent rows to improve sealing along the suture and prevent leakage.

In the following description, the descriptors and reference numbers associated with fig. 1-7 will be used for consistency, but it should be understood that alternative configurations such as those shown in fig. 8 may also be used. Accordingly, when referring to a staple cartridge, reference numeral 70 of fig. 1-7 will be utilized, but it should be understood that the present disclosure also applies to the staple cartridge 600 of fig. 8.

According to one aspect of the invention, local pre-cooling of the tissue immediately prior to suturing facilitates better surgical results. The linear stapler has a cooling zone that allows cooling of the tissue immediately before stapling after the stapler is positioned on/in the tissue. The cooling zone is located in or adjacent to a tissue-facing surface of the lower jaw (50 or 530) and/or anvil (60 or 320) or/and is represented by: a coolant reservoir containing pre-cooled coolant or immediate coolant; a coolant reservoir connected to the recirculating coolant; an electrically cooled peltier element; a compressed gas cooling orifice connected to the gas conduit and the compressed gas source; a heat pipe to transfer thermal energy between the lower jaw and/or anvil and a cooling zone in the stapler handle (20,310,510). The cooling zone is configured to transfer thermal cooling energy to the tissue-facing surface such that tissue in contact with the tissue-facing surface is pre-cooled prior to stapling.

Turning now to FIG. 9, there is shown a simplified cross-sectional view of an embodiment of the surgical stapling and severing instrument 10a of the present invention wherein the anvil 60a has a coolant chamber or reservoir or compartment 1030 therein.

Similarly, FIG. 10 shows a simplified cross-sectional view of an embodiment of a surgical stapler 11a of the present invention wherein anvil 320a has a coolant chamber or reservoir or compartment 1030 therein.

Fig. 11 shows a simplified cross-sectional view of an anvil 60 known in the art without a coolant compartment 1030 having an upper portion 1003, a sidewall 1002, a tissue-facing end or staple-facing surface 1001 with longitudinally extending channels 62 and a plurality of staple forming pockets 64 in a staple bending zone 1025. A cross-section is taken across the longitudinal axis of the anvil 60 and viewed from the distal end of the anvil 60.

Turning now to fig. 12A-12G, a schematic cross-sectional view of the anvil 60a of the present invention is shown. The cross-section is taken across the longitudinal axis of the anvil 60a and viewed from the distal end of the anvil 60 as indicated by the arrows in fig. 9.

Fig. 12A shows an embodiment of an anvil 60a having an enclosed coolant chamber or coolant reservoir or coolant compartment 1030a filled with coolant therein. The coolant compartment 1030a can have any shape, including rectangular, cylindrical, spherical, elliptical, toroidal, cubic, conical, truncated conical or frusto-conical, combinations thereof, and the like. As shown, the coolant compartment 1030a is generally rectangular and extends across the width of the anvil 60a and along the length of the anvil 60a below the upper portion 1003 between the sidewalls 1002.

Fig. 12B shows an embodiment similar to that shown in fig. 12A, but with an expanded coolant compartment 1030B having a larger subchamber adjacent the side wall 1002 that is configured to occupy as much of the available space inside the anvil 60a as possible. An optional fill port is shown terminating on the upper portion 1003 and covered with a cap 1005. The coolant compartment 1030b is positioned closer to the staple bending zone 1025 and the staple facing surface 1001.

Fig. 12C shows an embodiment similar to the embodiment shown in fig. 12A, 12B, but with two unconnected subchambers of coolant compartment 1030C inside anvil 60 a.

Fig. 12D shows an embodiment with an optional heat transfer area 1006 extending from contact with the coolant compartment 1030D toward the staple buckling region 1025 and/or the staple facing surface 1001. The optional heat conducting area 1006 forms the staple bending area 1025 and/or the staple facing surface 1001 and is made of any highly thermally conductive metal or alloy, including but not limited to copper or copper-based alloys, aluminum or aluminum alloys, brass, etc., wherein the thermally conductive metal or alloy has a thermal conductivity that exceeds the thermal conductivity of stainless steel, such as at least twice the thermal conductivity of stainless steel, and more preferably five times the thermal conductivity of stainless steel. This configuration facilitates heat transfer and cooling of tissue adjacent to and in contact with staple bending zone 1025 and/or staple facing surface 1001, and prevents heat transfer and cooling of tissue not adjacent to and in contact with staple bending zone 1025 and/or staple facing surface 1001.

FIG. 12E illustrates an embodiment that also has an optional insulating outer coating 1007 on the outer surface of the anvil 60a, such as on the side walls 1002 and/or upper portion 1003, but does not cover the staple bending zone 1025 and/or staple facing surface 1001, regardless of the presence of the optional heat transfer zone 1006 (as shown). Also shown is an optional thermally insulating inner coating 1008 on the inner surface of the coolant compartment 1030e that does not cover portions of the coolant compartment 1030e adjacent the staple buckling region 1025 and/or the staple facing surface 1001, whether or not the optional heat conducting region 1006 is present (as shown). This configuration facilitates heat transfer and cooling of tissue adjacent to and in contact with staple bending zone 1025 and/or staple facing surface 1001, and prevents heat transfer and cooling of tissue not adjacent to and in contact with staple bending zone 1025 and/or staple facing surface 1001.

In all embodiments, the thermal energy of the coolant contained in the compartment 1030 is used to facilitate heat transfer from the tissue to the coolant and to cool the tissue immediately prior to stapling.

Referring to fig. 12F, at least one or more

optional windows

1009a, 1009b, 1009c are mounted on the upper portion 1003 and/or the side wall 1002, which can then be used to detect a two-phase ice/water mixture in the coolant compartment 1030b, which indicates a temperature of 0 ℃ if pure water; and another temperature if it is a cooled mixture, such as a salt/water cooled mixture with a lower liquid/freeze equilibrium temperature.

Referring to fig. 12G, an optional temperature probe, sensor or indicator 1010 may be mounted on the anvil 60a, such as on the upper portion 1003 or the sidewall 1002, including an electronic indicator, a color change indicator, a bi-metallic temperature indicator, or the like. The temperature probe 1010 may also include ports for measuring the electrical output of thermocouples, thermistors, and similar sensors mounted inside the compartment 1030 b.

In accordance with at least some embodiments of the present invention, the coolant reservoir or compartment 1030 contains a coolant, preferably a fluid coolant, which preferably has a high thermal or heat capacity, and thus can store a large amount of cooling energy, which is then transferred to the tissue for tissue cooling immediately prior to stapling. High heat capacity or heat capacity materials are characterized by a high specific heat capacity, with the preferred coolant being water, physiological saline, or any aqueous solution. Pure water or water containing a trace amount of dissolved compounds, which has a very high heat capacity of about 4J/g/K, may be used as the coolant. The brine mixture may be used at temperatures below 0 ℃.

The compartment 1030 may hold 1g to 20g, such as 1g, 2g, 3g, 4g, 5g, 6g, 7g of water. Providing e.g. 5g of water inside the compartment 1030 will result in the following cooling energy generation. In the case where the water inside the compartment 1030 is initially heated to +10 ℃ at +5 ℃ during cooling of the tissue, the cooling zone will absorb an amount of energy from the surrounding region (which includes the tissue) equal to about 5g by 5 ℃ by 4 to 100J.

Water is also characterized by a very high enthalpy of fusion (latent heat of fusion), which is the amount of energy consumed or released during a phase change, such as melting, where water has a specific heat of fusion of about 334J/g. In one embodiment, the water inside the coolant reservoir or compartment 1030 is initially chilled, i.e., converted to ice. The amount of energy absorbed from the surrounding area when the ice melts at 0 ℃ will be equal to about 5g 334 ═ 1670J. If the melted water is then heated to +10 ℃, the additional amount of energy consumed and absorbed from the surrounding area (which includes tissue) is equal to about 5g by 10 ℃ by 4 to 200J. Considering that the target tissue weighs between 1g and 5g, it is contemplated that the target tissue is sufficiently cooled to a normal tissue temperature below 36.6 ℃, such as to +3 … … +15 ℃, such as to a temperature of about +5 ℃, +7 ℃, +10 ℃ immediately prior to stapling during a brief contact period with the anvil 60a (such as within 5 seconds to 300 seconds, more preferably within 10s to 120s, such as within 10s, 20s, 30s, 60 s).

Preferably, the tissue is not frozen upon contact with the cryogenic or cooled anvil 60a of the present invention and there is no permanent tissue damage. Thus, the temperature of the surface in contact with the tissue is configured to be lower than the tissue temperature, such as about-10 ℃ to about +10 ℃ or even up to 20 ℃, such as-5 ℃, -3 ℃,0 ℃, +3 ℃, +5 ℃, +10 ℃. For the purposes of this disclosure, the term "cryogenic" means effectively lowering the temperature of tissue relative to normal body temperature in the immediate vicinity of the device by some artificial means as further described herein.

In some embodiments, the coolant fluid comprises a material or mixture having a freezing point above or below 0 ℃. In one embodiment, a mixture of water salts, a mixture of water alcohols and a mixture of water glycerol are used, all having a freezing point below 0 ℃. In one embodiment, a mixture of water and glycerol is used, the freezing point of which is above 0 ℃ and the concentration of glycerol (% by weight) is between 90% and 98.3%, resulting in a freezing point between-1.7 ℃ and +13 ℃, in particular glycerol at a concentration of from 93% to 95% can be used to produce a melting or freezing point of the mixture above 0 ℃ but below +8 ℃.

The cooling of the tissue is intended not to result in any permanent damage to the tissue or freezing of the tissue. While the cooling compartment may be below 0 ℃, it only takes place instantaneously and for a short time, such as 1s, 3s, 10s, 20s, when the tissue cools itself to below 0 ℃. Similarly, when the tissue is cooled to a low temperature, such as 5 ℃, it is also only performed instantaneously and for a short time, such as 3s, 10s, 20s, 60 s.

In some embodiments, immediate cooling is provided inside compartment 1030 using an endothermic reaction that dissolves the salt in water. The salt used may be ammonium nitrate, calcium ammonium nitrate, urea or similar salts, whereby the salt is separated from the water by a frangible separator or membrane. Referring to fig. 13A, in one embodiment, a salt 1013A having a dissolved high enthalpy of endotherm is filled into a compartment 1030e, wherein a frangible pouch 1012a containing water is also placed inside the compartment 1030 e. An actuating rod 1011 is provided that is configured to be accessed from the exterior of anvil 60a and is adapted to reach frangible bag 1012a inside compartment 1030 e. Actuation of the rod 1011 to break the frangible bag 1012a releases water from the bag 1012a, resulting in mixing of the salt with the water, dissolving the salt in an endothermic reaction, and immediate cooling of the anvil 60 a.

Referring to fig. 13B, in another embodiment, the salt is enclosed in a frangible pouch 1012B placed inside a compartment 1030e filled with water 1013B. Actuation of the rod 1011 to break the frangible pouch 1012b releases salt from the pouch 1012b, causing the salt to mix with water, dissolving the salt in an endothermic reaction, and immediate cooling of the anvil 60 a.

The immediate coolant mixture can be activated for cooling to occur before any contact is made with the tissue being joined or immediately after the tissue is compressed prior to stapling.

Referring to fig. 14A, there is shown a simplified cross-sectional view of an embodiment of the surgical stapling and severing instrument 10b of the present invention wherein the anvil 60b has a coolant chamber or reservoir or compartment 1030f externally attached to the anvil 60 b. Referring additionally to fig. 14B, a simplified cross-sectional view of an embodiment of the anvil 60B of the present invention is shown wherein a coolant compartment 1030f is secured to the upper portion 1003 of the anvil 60B via attachment fasteners 1031B located in the center of the upper portion 1003 and/or fasteners 1031a located on the periphery of the upper portion 1003. In all cases, the

fasteners

1031a, 1031b enable quick attachment and removal of the coolant compartment 1030 f. The attachable and detachable external coolant compartment 1030f comprises a generally rectangular elongated body, as shown in fig. 14C. In a preferred embodiment, the external coolant compartment 1030f is hollow and filled with coolant. In an alternative embodiment, the external coolant compartment 1030f comprises a solid non-hollow body made of metal.

Similarly, with respect to the embodiments of the present invention shown above, where the cooling zone is located in or on the

anvil

60a, 60b, 320a, the cooling zone including a coolant reservoir or coolant compartment may also be positioned in or on the lower jaw (50 or 530) (not shown).

In some embodiments (not shown), an optional thermally conductive area, such as thermally conductive area 1006, is provided that extends from the coolant compartment to the tissue-facing surface of the deployed staples of the stapling

cartridge

70, 600.

In some embodiments (not shown), instantaneous cooling is provided inside the cooling compartment using an endothermic reaction that dissolves the salt in water (as in the embodiment of fig. 13A, 13B), wherein an actuation rod, such as actuation rod 1011, is configured as a frangible bag that is accessible and adapted to reach the inside of the cooling compartment.

Referring now to fig. 15, in some embodiments of the surgical stapling and severing instrument 10c of the present invention, a recirculating coolant reservoir or cooling compartment 1034 is provided in the anvil 60c into which cooled coolant is supplied via a supply channel 1050a and a discharge channel 1050b, such channels terminating adjacent to or on the handle assembly 20, such as on the pistol grip 22 as shown, and connected to a supply/discharge line 1052 which is connected to a pump and cooler 1054 adapted to supply cooled fluid coolant. The pump and cooler 1054 can be positioned external (as shown) or internal (not shown) to the stapler 10 c. In operation, the recirculation of the cooled fluid coolant reduces the temperature of the anvil 60c to a desired temperature of about 0 ℃ to about 10 ℃ (such as 5 ℃). The recirculation may continue during the stapling operation or may stop before stapling. The coolant reservoir or cooling compartment 1034 may include a chamber or tubular coil.

Optionally, prior to stapling, the anvil 60c is brought into contact with the lower jaw 50 and pre-cooled using conductive heat transfer for several minutes, such as 5 to 60 minutes.

According to another embodiment of the surgical stapling and severing instrument 10d of the present invention, schematically illustrated in cross-section in fig. 16, cooling and/or pre-cooling of the anvil 60d and/or the lower jaw 50d and/or the stapling cartridge 70d is performed by a throttling process or Joule-Thomson process or adiabatic expansion cooling, thereby allowing the compressed gas to expand from a higher pressure to a lower pressure and discharge into the surrounding space through an orifice, valve or porous permeable plug. Referring to fig. 16, a source of compressed gas, such as air, CO2, nitrogen, or the like, is provided. The source may be a balloon with compressed gas, such as balloon 1060a located inside the pistol grip 22, balloon 1060b located proximal to the handle 20 and connected thereto via gas port 1062a, or a source of compressed gas (not shown) may be distal to the handle 20 and connected to gas port 1062b via gas supply line 1064.

The gas conduit line 1066a is configured to deliver compressed gas from the region of the handle 20 toward the anvil 60d and/or lower jaw 50d, terminating at one or more orifices positioned as shown, wherein the conduit line 1066c in the lower jaw 50d feeds the orifice 1068a at any location on the stapling cartridge 70d, the

orifices

1068b and 1068c on the lower jaw 50 d.

Additionally or alternatively, the gas conduit line 1066b is configured to convey the compressed gas provided by the conduit 1066a from the region of the handle 20 toward the anvil 60d, terminating in one or more orifices positioned as shown, wherein the orifice 1069a is located on the tissue-facing surface of the anvil 60d and the orifice 1069b is located on the upper portion 1003 of the anvil 60 d.

The compressed gas released from orifices 1068, 1069 is schematically illustrated by the gas cloud symbol in fig. 16. The orifices 1068, 1069 have a diameter of about 20 microns to about 2000 microns, such as 30 microns, 50 microns, 100 microns, 200 microns, 300 microns, 500 microns, 800 microns, 1000 microns, 1500 microns.

Cooling of the compressed gas may be performed prior to compressing the tissue between the anvil 60d and the lower jaw 50d using either or both of the orifices 1068, 1069. The cooling of the compressed gas may also be performed after compressing the tissue between the anvil 60d and the lower jaw 50d, but before stapling, by using only orifices not located on the tissue-facing surface, i.e. orifices 1069b and/or 1068b, 1068 c.

In an alternative embodiment, a cooling zone is provided that includes a peltier element (not shown) whose cold plate is positioned adjacent the tissue-facing surface of the

staple cartridge

70, 600, or more preferably adjacent the tissue-facing or staple-facing surface 1001 of the anvil 60 a. Supplying electrical energy to the peltier element causes the tissue-facing surface to cool.

In another embodiment, the cooling zone may comprise a heat pipe configured to transfer thermal energy between the lower jaw and/or anvil and a heat sink zone in the stapler handle.

In operation of all embodiments, the cooling surface in contact with the tissue is maintained near or above the tissue freezing temperature, such as above-3 ℃, -2 ℃, -1 ℃,0 ℃, most preferably above 0 ℃, such as at 0 ℃, +1 ℃, +2 ℃, +4 ℃, +5 ℃, +6 ℃, +8 ℃, +10 ℃, to avoid tissue freezing to the stapler and to avoid thermal damage to the tissue. In some embodiments, the cooling zone is at a temperature below the tissue freezing temperature, such as at-10 ℃, but upon contact with the tissue and heat exchange between the cooling zone and the tissue, the temperature rapidly increases to above the tissue freezing, such as above 0 ℃, such as to 0 ℃,3 ℃,5 ℃.

Referring now to fig. 17, there is shown a schematic cross-sectional view of an anvil 60a and lower jaw 50a having a stapling cartridge 70 wherein the anvil 60a is similar to the cartridge 70 in preparation for stapling and excising upper tissue T1 and lower tissue T2 wherein the tissue is compressed between the anvil 60a and the cartridge 70 (lower jaw 50 a). The upper tissue T1 is in contact with the staple bending zone 1025 and staple facing surface 1001 of the anvil 60a, while the lower tissue T2 is in contact with the stapling cartridge 70 and lower jaw 50 a.

The position shown is prior to deployment of the staples. For simplicity, the staple deployment mechanism of the staple pockets 74 and the mechanism for deploying the tissue cutting knife through the channel 72 are not shown. For simplicity, the anvil 60a is shown as an embodiment similar to the embodiment of fig. 12B having the coolant compartment 1030B. However, any of the above described embodiments of the anvil 60 and cooling elements of the anvil 60 may be utilized, including a coolant compartment 1030 in or on the anvil, which contains coolant and/or frozen coolant; an immediate coolant that utilizes an endothermic reaction that dissolves salt in water; recirculating the coolant; an electrically cooled embodiment; compressed air cools the embodiments. Similarly, any of the above-described embodiments of the lower jaw 50 can be utilized.

All of the above elements that facilitate cooling of the anvil and/or lower jaw may be activated prior to compressing the tissues T1 and T2 between the anvil 60a and the cartridge 70 (lower jaw 50 a). Additional immediate coolant, recirculating coolant; the electrical (peltier) cooling element may be activated before or after compressing the tissues T1 and T2. Additionally, as described above, gas cooling mechanism orifices that do not face tissues T1 and T2 may also be activated before or after compressing tissues T1 and T2.

As can be appreciated from fig. 17, once the tissues T1 and T2 are compressed between the anvil 60a and the cartridge 70 (lower jaw 50a), the tissues T1 and T2 are cooled by conductive heat transfer, particularly in the areas of contact with the anvil 60a and/or the cartridge 70. Such cooling may be performed for any convenient time, preferably for at least 5 to 10 seconds, such as 10, 20, 30, 60, 120, 300, 600 seconds, in preparation for suturing.

After the compressed tissues T1, T2 have substantially cooled, e.g., to a temperature below 36.6 ℃ body temperature, such as to a temperature of about 3 ℃ to about 20 ℃, such as 5 ℃,10 ℃, 15 ℃, 20 ℃, the staples are actuated, staples (not shown) are deployed from the staple cartridge 70 and engage the tissues T1 and T2 while optionally excising the tissue between the sutures.

Referring now to fig. 18, the configuration of the embodiment of fig. 17 is shown after stapling, i.e., with staples 77 deployed to establish a stapled joint between tissues T1 and T2 and the tissue cut by the knife member.

After deploying staples 77 and cutting tissue, the linear stapler is withdrawn by opening or separating anvil 60a and lower jaw 50 a. Advantageously, by pre-cooling these regions, the regions of tissue T1 and T2 that are cut and stapled are advantageously protected from excessive damage. The linear stapler may be withdrawn immediately after suturing. In an alternative embodiment, the freshly sutured and excised tissue is cooled for a brief period of time by successively compressing the sutured tissue for at least an additional 5s (such as 10s, 30s, 60s, 300s, 600 s).

According to an embodiment of the present invention, the order of using or operating the

linear staplers

10a, 11a, 10b, 10c, 10d while engaging tissue is as follows:

a) positioning tissue T1 and T2 between the anvil 60a and the lower jaw 50 a;

b) approximating the anvil 60a and lower jaw 50a and compressing the tissue T1 and T2 against the anvil

60a and lower jaw 50 a;

c) firing stapler 10a and establishing a stapling joint between tissues T1 and T2; and

d) opening or separating the anvil 60a and lower jaw 50a and withdrawing the stapler 10a from contact with the tissues T1 and T2.

The complete and all steps for the suturing and resection surgery are not listed above, but the skilled person will know these steps. The temperature of the cooling zone can be shifted from-10 ℃ to +20 ℃ or from +20 ℃ to-10 ℃ in a short time and does not have to be kept constant during contact with the tissue. The temperature of the tissue may decrease from the normal tissue temperature to at least 5 degrees celsius, such as 5 degrees celsius, 10 degrees celsius, 15 degrees celsius, 20 degrees celsius, 30 degrees celsius, 40 degrees celsius, upon contact with the cryogenic stapler and/or the cooling zone. In some embodiments, the tissue temperature in the area to be sutured is reduced to reach 0 ℃,5 ℃,10 ℃.

According to an embodiment of the invention, the cooling related steps are performed in the following order:

a coolant compartment and an externally attached cooling chamber embodiment. The coolant in the coolant compartment 1030 is pre-cooled or frozen prior to positioning the tissues T1 and T2 between the anvil 60a and the lower jaw 50a, as outlined in step a) above. Similarly, the externally attached cooling chamber 1030f is pre-cooled or frozen prior to positioning the tissues T1 and T2 between the anvil 60a and the lower jaw 50a, as outlined in step a) above.

An instant coolant embodiment. As outlined above, the instant cooled mixture in compartment 1030e is activated before step a) or before step c). Most preferably the immediate cooling mixture is activated prior to step a).

A recirculating cooling embodiment. Cooling in recirculating cooling compartment 1034 is initiated or activated prior to step a), or prior to step b), or prior to step c). Cooling is achieved by recirculation of coolant and may be stopped after the cooled compartment is sufficiently cooled, optionally before steps a), b), or before step c), or before step d), as outlined above. Alternatively, the recirculation of the coolant is continued from before step a) to after step d).

The electrical cooling can be initiated or activated before steps a), b), c). The electrical cooling is induced by supplying electrical power to the peltier elements.

The compressed gas cooling may be initiated or activated before step a) and will be stopped before step b). Compressed gas cooling is induced by purging gas through gas conduit line 1066a and/or 1066b and allowing the gas to vent through

orifice

1068a, 1068b, or 1068c and/or through

orifice

1069a or 1069b (which may be in an anvil, cartridge, or lower jaw).

The volume of

compartments

1030, 1034 is selected to allow fitting within or upon anvil 60a and/or lower jaw 50 without interfering with the stapling mechanism and is about 1cm³To about 20cm³More preferably 2cm³To 10cm³Such as 2cm³、3cm³、5cm³、8cm³、10cm³。

While the invention has been described above with reference to specific embodiments thereof, it is apparent that many changes, modifications, and variations can be made without departing from the inventive concept disclosed herein. Accordingly, it is intended to embrace all such changes, modifications, and variations that fall within the spirit and broad scope of the appended claims.

Claims

1. A cryosurgical stapler for stapling and optionally resecting at least one tissue, comprising:

a body, a shaft assembly, and an end effector, wherein the end effector comprises a lower jaw configured to receive a staple cartridge, an anvil pivotable toward and away from the lower jaw, and a translatable knife member;

a disposable cartridge mounted in the lower jaw, the cartridge containing a plurality of deployable staples in an array separated by a tissue resection channel through which the knife member is translatable;

the anvil has a plurality of staple forming pockets on a tissue-facing surface aligned with the deployable staples;

wherein the stapler includes at least one cooling zone.

2. The cryosurgical stapler of claim 1, wherein the cooling zone comprises a reservoir filled with a coolant, the reservoir being located inside the anvil and positioned adjacent to a tissue-facing surface of the anvil.

3. The cryosurgical stapler of claim 1, wherein the cooling zone comprises an externally attached cooling chamber positioned on the anvil.

4. The cryosurgical stapler of claim 1, wherein the cooling zone has a temperature of about-10 ℃ to about +10 ℃ prior to stapling.

5. The cryosurgical stapler of claim 2, wherein the coolant comprises a fluid having a high heat capacity.

6. The cryosurgical stapler of claim 1, further comprising a probe configured to indicate a temperature of the cooling zone.

7. The cryosurgical stapler of claim 2, wherein the coolant is a combination of a frozen coolant and a molten coolant.

8. The cryosurgical stapler of claim 2, wherein the coolant comprises water, alcohol, glycerol, ethylene glycol, or mixtures thereof.

9. The cryosurgical stapler of claim 2, wherein the coolant comprises a glycerol-water mixture having a melting point above 0 ℃ but below 8 ℃.

10. The cryosurgical stapler of claim 2, wherein a thermally conductive area extends from a tissue-facing surface that is in contact with the reservoir toward the anvil.

11. The cryosurgical stapler of claim 2, wherein the reservoir has at least one window.

12. The cryosurgical stapler of claim 2, wherein the coolant comprises an immediate coolant.

13. The cryosurgical stapler of claim 2, wherein the reservoir is connected to a recirculation pump and cooler via a supply channel and a drain channel.

14. The cryosurgical stapler of claim 1, wherein the cooling region comprises a compressed gas cooling orifice connected to a gas conduit and a compressed gas source.

15. The cryosurgical stapler of claim 1, wherein the cooling region comprises a heat pipe configured to transfer thermal energy between the anvil and a cooled heat sink region in the stapler handle.

16. The cryosurgical stapler of claim 1, wherein the cooling region comprises a peltier element.

17. A method of using the surgical stapler of claim 1, comprising the steps of:

a) inserting the staple cartridge into the lower jaw;

b) capturing the tissue between the anvil and the staple cartridge;

e) optionally continuing to cool the stapled tissue;

f) removing the surgical stapler from contact with tissue.

18. The method of claim 17, wherein the cooling zone is pre-cooled or frozen prior to step a) or b) or c).